Progressive Keratoconus Clinical Trial
Official title:
A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus
Verified date | January 2024 |
Source | Glaukos Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to penetrate the cornea without the need to remove the epithelium, the outer most layer of the cornea.
Status | Completed |
Enrollment | 201 |
Est. completion date | August 10, 2020 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 55 Years |
Eligibility | Inclusion Criteria: 1. Be between 12 and 55 years of age, male or female, of any race; 2. Provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 (or have not yet reached the age of majority per local regulations) will need to sign an assent form as well as having a parent or legal guardian sign an informed consent 3. Ability to read English or Spanish to complete the NEI-VFQ 25 questionnaire; 4. Willingness and ability to follow all instructions and comply with schedule for follow-up visits; 5. For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of each study eye; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit, and continue to use the method for one month following the treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); 6. Having topographic and clinical evidence of keratoconus Exclusion Criteria: 1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components; 2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study; 3. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. 4. A history of delayed epithelial healing in the eye to be treated or a current condition that may interfere with or prolong epithelial healing; 5. A history of previous corneal cross-linking treatment in the eye to be treated; 6. Have used an investigational drug or device within 30 days of screening or be concurrently enrolled in another investigational drug or device trial within 30 days of the study. |
Country | Name | City | State |
---|---|---|---|
United States | Ophthalmic Consultants of Boston | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Glaukos Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax | Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups | 6 months | |
Secondary | Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax | Difference between the CXL and Sham/Control treatment groups in the change from baseline to Month 12 in Kmax | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02721628 -
Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
|
N/A | |
Completed |
NCT02883868 -
Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency?
|
N/A | |
Active, not recruiting |
NCT04427956 -
Corneal Crosslinking Treatment Study
|
Phase 4 | |
Terminated |
NCT01868620 -
Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.
|
N/A | |
Recruiting |
NCT05314738 -
Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06450470 -
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
|
Phase 3 | |
Completed |
NCT02117999 -
Transepithelial Corneal Cross-linking Using Iontophoresis
|
N/A | |
Completed |
NCT01485211 -
Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin
|
Phase 4 | |
Completed |
NCT04504578 -
Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas
|
N/A | |
Completed |
NCT00567671 -
Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
|
Phase 2/Phase 3 | |
Completed |
NCT00647699 -
Corneal Collagen Cross-linking for Progressive Keratoconus
|
Phase 3 | |
Recruiting |
NCT00815256 -
Safety and Effectiveness of Collagen Cross Linking in Progressive Mild and Moderate Keratoconus
|
Phase 3 | |
Recruiting |
NCT04045626 -
Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns
|
N/A | |
Withdrawn |
NCT00679666 -
Corneal Crosslinking in Keratoconus and Corneal Ectasia
|
Phase 2/Phase 3 | |
Completed |
NCT01411384 -
Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus
|
N/A | |
Not yet recruiting |
NCT00925327 -
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
|
Phase 2 |